Status:
TERMINATED
Effectiveness Study of the Ivivi SofPulse for Pain Amelioration in Adults With Mild to Moderate Knee Osteoarthritis
Lead Sponsor:
Amp Orthopedics, Inc.
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40-80 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine the effectiveness of non-thermal Pulsed Radio Frequency (PRF) treatment with the Ivivi SofPulse for amelioration of knee pain in patients with mild to moderat...
Detailed Description
This prospective, double-blind, randomized, sham-controlled clinical trial will investigate the effectiveness of PRF using the Ivivi SofPulse on knee pain severity in adults with mild to moderate knee...
Eligibility Criteria
Inclusion
- Age 40 to 80 years
- Bilateral weight-bearing anteroposterior x-ray of each knee taken within the last 12 months and radiographs submitted to the Principal Investigator for evaluation
- Radiographic evidence of mild to moderate (Kellgren/Lawrence grade 2 or 3) OA in at least one knee based on a weight-bearing anteroposterior x-ray taken within the last 12 months
- Self-reported persistent knee pain severity of 4.0 to 8.0 cm on a 10 cm VAS for most days in the previous 2 months in at least one knee, with grade 2 or 3 OA
- Able to read and complete English-language surveys
- Daily access to the internet
- Ability of the participant to comprehend the full nature and purpose of the study including possible risks and side effects
- Consent to the study and willing to comply with study methods
Exclusion
- Subjects who have any implanted metallic leads, wires, or systems (e.g. pacemaker, implantable cardioverterdefibrillator)
- Self-reported persistent knee pain severity \> 8.0 cm on a 10 cm VAS in either knee for most days in the previous 2 months
- Radiographic evidence of severe (Kellgren/Lawrence grade 4) OA in either knee based on a weight-bearing anteroposterior x-ray taken within the last 12 months
- Self-reported diagnosis of autoimmune or inflammatory arthritis (e.g. Rheumatoid Arthritis, Lupus, etc.)
- More than 8 days of narcotic pain medication in the last 30 days
- Joint surgery, tidal lavage, or arthroscopy of either knee in the past 6 months
- Intra-articular corticosteroid or hyaluronic acid injections of either knee in the past 6 months
- Oral prednisone use in the past 30 days
- Participation in any clinical trial in the past 30 days
- Knee OA associated with worker's compensation or accident litigation
- Regular use of a walker or wheelchair
- Vulnerable populations including prisoners and nursing home residents
- Anticipated move away from immediate area in next 6 months
- Any medical condition that, in the opinion of the investigator, may compromise patient safety or confound the assessment of treatment effectiveness
- After 1-week Run-in Period
- Daily average of "current" knee pain severity \< 4.0 cm, assessed on a 10 cm VAS, during the 1-week run-in period in both knees
- Daily average of "current" knee pain severity \> 8.0 cm, assessed on a 10 cm VAS, during the 1-week run-in period in either knee
- Daily average of "current" knee pain severity of 4.0 to 8.0 cm, assessed on a 10 cm VAS, during the 1-week run-in period in any knee with Kellgren/Lawrence grades of 0 or 1 in the same knees
- Narcotic use of more than 2 days during the 1-week runin period
- Noncompliance with online symptom reporting requirements
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01457742
Start Date
October 1 2011
End Date
July 1 2012
Last Update
July 10 2012
Active Locations (1)
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1
Mytrus, Inc.
San Francisco, California, United States, 94104